Metastatic Breast Cancer Clinical Trial
— KS2422-vaccOfficial title:
Phase 1 Study: Induction of Systemic Immune Responses in Metastatic Breast Cancer Patients by Vaccination With a CD80-modified, Devitalized HLA-*A0201+ Breast Cancer Cell Line (KS24.22)
In the last few years there has been a great attempt to develop active immunotherapies for breast cancer patients (BCPs) using undefined as well as selected antigens to activate tumor specific T-lymphocytes. The purpose of this phase-I study was to determine the safety and feasibility of vaccinations with an allogeneic breast cancer cell line, KS24.22, genetically modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor antigen-specific immune responses in human leukocyte antigen(HLA)-A*02-matched patients with metastatic breast cancer.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 2010 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - proven diagnosis of carcinoma of the breast with distant metastatic disease - patient received either anthracycline- or taxane-based chemotherapy ("state of the art") - Karnofsky Score (performance status) 80% - HLA-*A0201-positive - minimum life expectancy of 6 month - written informed consent - activation of patient's T-lymphocytes by mitogen antibodies and the cell line used for vaccination Exclusion Criteria: - manifestation of CNS metastases - immunosuppressive disease like AIDS, autoimmune disease - no serious concomitant systemic medical disorders or active acute or systemic infection - pregnancy - chemotherapies or radiotherapies in the 4 weeks preceding study entry - biological response modifiers (antibodies, TNF, cytokines) or other immune therapies in the 6 weeks preceding study entry (exclusion: hematopoetic growth factors) - organ transplanted patients |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Univ. of Tuebingen, Dep. Obst. and Gynecology | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | Paul Ehrlich Institute, Langen, Germany |
Germany,
Gückel B, Stumm S, Rentzsch C, Marmé A, Mannhardt G, Wallwiener D. A CD80-transfected human breast cancer cell variant induces HER-2/neu-specific T cells in HLA-A*02-matched situations in vitro as well as in vivo. Cancer Immunol Immunother. 2005 Feb;54(2) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety of KS24.22 administration | 2 years | Yes | |
Primary | feasibility | Yes | ||
Secondary | immunological response | 2 years | No | |
Secondary | progression free survival | No | ||
Secondary | overall survival | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04872608 -
A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT02506556 -
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05534438 -
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03368729 -
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04103853 -
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
|
Phase 1 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Active, not recruiting |
NCT03147287 -
Palbociclib After CDK and Endocrine Therapy (PACE)
|
Phase 2 | |
Not yet recruiting |
NCT06062498 -
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04432454 -
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
|
Phase 2 | |
Recruiting |
NCT03323346 -
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05744375 -
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
|
Phase 2 | |
Completed |
NCT02924883 -
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
|
Phase 2 | |
Completed |
NCT01942135 -
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
|
Phase 3 | |
Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Completed |
NCT01401959 -
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
Phase 2 | |
Terminated |
NCT04720664 -
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
|
Phase 2 |